BPOG and BPSA User Requirements for

Single Use Systems

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Agenda

• Background: SUS Requirements Joint Team

• BPOG Member Survey

• Next Steps

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GMP Expectations Gap

• GMP Expectations Webinar (Q3-Q4 2014) • GMP – Survey of End users (March 2015)

Form the team

• BPOG Disposables ‘Face to Face’ Meeting – Decision to form a team to work on ‘Single Use - User Requirements’ (April 2015)

• Decision to form a joint team with support from BPSA. (Q2 2015)

Mobilize & Communicate

• BPSA Summit (July 2015) • BPI Conference (October 2015)

How did we get to this point?

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Current Team Members (15 End Users / 12 Suppliers)

End Users Suppliers

Abbvie Colder

Amgen Dow Corning

Astra Zeneca Entegris

Baxalta GE Healthcare

Biogen Millipore-Sigma

BMS Meissner

GSK NewAge Advantapure

GSK Biologicals Nordson Medical

Lonza Sartorius Stedim

Merck Saint-Gobain

Novavax Thermoscientific

Regeneron Value Plastics

Roche

Sanofi Pasteur

Shire

Excerpt from GMP Expectations Webinar

• For Single Use Systems to be the system of choice for GMP operation, the gap needs to close by creating a standard set of requirements

• Government agencies hold End Users accountable for any deficiencies in the quality of materials and data acquired from suppliers.

• End Users require systems around Single Use Systems to provide the same level of assurance as conventional stainless steel provides; this is driven by defined user requirements.

End User Supplier GMP Expectations Gap

‘Single Use Systems provide significant operational benefits’

‘However too often implementations of Single Use Systems in GMP Operations expose a gap in expectations between Supplier and End User on GMP’

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Excerpt from GMP Expectations Webinar ‘Collaboration of Suppliers and End Users is vital to the establishment of standard user requirements that are harmonized and at the same time defendable to regulatory inspection’

A strong foundation for the creation of Single Use System

standards and ways of working.

A consistent, defendable position

for regulatory inspection.

More rapid integration of Single

Use Systems into Commercial and

Late Phase programs.

Accurate knowledge of

Customer’s needs, reducing waste for

all concerned.

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As Single Use System assemblies replace traditional equipment, the Supplier starts to own a larger portion of the supply chain and the End User’s direct control diminishes

But the End User remains accountable!

N-2

N-1 Supplier CIP/SIP

Assembly and Verify

Run

Supplier End User

N-2

N-1 Supplier CIP/SIP

Assembly and Verify

Run

Supplier End User

Before

Now

N-2

N-1 Supplier CIP/SIP

Assembly and Verify

Run

Supplier End User

Needs to be

Disciplined development of URS

Disciplined development of URS

Uncharted space -Ad-hoc development of needs/requirements

The ‘New Reality’ for Single Use Systems

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Quality and Compliance

Meet Agency Requirements

Well Defined Materials

Control of Supply Chain

*Shared Responsibility (End users and Suppliers)

*

Requirements of Single Use Systems in a Commercial Operation

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Agenda

• Background: SUS Requirements Joint Team

• BPOG Member Survey

• Next Steps

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GMP Expectations Survey of End Users

Pre-evaluation of Single Use System

What is important and where do you focus

before you implement SUS?

Component production,

understanding the film system, engagement

qualification, etc...

Quality System Requirements

(verified during audits)

What is important and what do you ask about

during audits?

Environment, documentation,

equipment, sterilization validation

Product Specification Requirements

What information do you ask for when your

product arrives for use?

QC release testing, visual inspection

criteria...

The survey was designed to gather feedback focused on three main stages of evaluation of a Supplier by an End User:

15 End User companies participated 10

GMP Expectations Survey of End Users

Pre-evaluation of SUS system

We get this every time

We sometimes get this

We never get this

We never ask this

High Importance

Neutral

Not Important

Quality system requirements (audits)

We always review this

We sometimes review this

We never review this

High Importance

Neutral

Not Important

Product Specification Requirements

We get this every time

We sometimes get this

We never get this

We never ask this

High Importance

Neutral

Not Important

Participant Responses were reviewed using a heat map approach

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Survey Results (Pareto Chart - Dissatisfaction levels)

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Class VI and Shelf-life Studies reached high satisfaction levels

Aspects addressed 5 10 17

Improvement (%) 23 54 82

GMP Expectations Survey of End Users

Overall survey results showed the following:

– The areas of focus chosen were of high importance to most companies.

– Companies have varying levels of success getting this information.

Why? • Is the information not known? • Can this information not be shared? • Do different company approaches generate different results? • Does company size have an effect (both supplier and end user)?

– Those which were ranked of high importance are opportunities to collaborate and understand best practice.

– There was a 50/50 split of end user companies who have suppliers that cannot be used because they cannot meet GMP expectations.

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ALIGNMENT OPPORTUNITIES

MOC

Engagement Integrity (+ tubing,

connectors, etc....)

Particulate / visible

Comp. Performance testing

Mfg. Environment

Supplier Inspection of SU

Bioburden sampling

Supply Chain transparency

LAL product per lot

KPI during mfg.

Understanding film props and other components (+ tubing, connectors, etc....)

Monster assembly (LAL and validation, bioburden)

Integral connections

Sup. Documentation Practices

Sup. Equip. Mgmt. Program

Operator Training Program No delamination or defective seals

Reluctance to work with some suppliers

No esthetical defects

EM Robustness

Supplier Gowning Practices

Film Layer identification

ISO 11137 Validation

Understanding the application

Integrity/ Performance

Visual release criteria

Particulate

Mfg environment

C of A Release

MOC of Film & Components

Mfg. systems / practices / education

GROUPING OF SURVEY RESULTS PER JOINT DISCUSSION

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Includes the performance of application / assembly

DIS

SATI

SFAC

TIO

N

DIS

SATI

SFAC

TIO

N

Areas of Focus Established from the Survey Results

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Pre-Evaluation

MOC

Integrity / Performance

Supplier Qualification/

Capabilities

Manufacturing Systems / Practices / Education

Manufacturing Environment

Product Specification

Visual Release Criteria

C of A Release

Agenda

• Background: SUS Requirements Joint Team

• BPOG Member Survey

• Next Steps

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Joint Team - Plan

Form collaboration between End

Users and Suppliers to

develop a joint path forward

for the creation of Standard

User Requirements

Review feedback from

end user survey to help narrow down to the focus

areas

Establish scope and strategy

Publish guidance

based on joint work – through

articles, development of standards for

SUS, etc....

Obtain feedback and

revise guidance as appropriate.

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White Paper Guidance & User Requirement Documents

White Paper Guidance

Supplemental Audit Guide

Outputs

User Requirements

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Pre-evaluation

Supplier Audits

Product Specification

Key concerns? Ideas? Best practices?

Tell people in your company about this effort.

Please share your feedback or express your interest via e-mail

Email your feedback and comments to: userrequirements@biophorum.com

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